Medical infusion pumps are used to infuse liquids, such as nutrients and medicaments, into the circulatory system of a patient. Such pumps provide a wide range of flexibility in administering such fluids. For instance, the rate at which a medicament is introduced into the circulatory system can be variably programmed, the total volume to be administered can be pre-set, and the time for administering the medicament can be scheduled for automatic delivery at a certain periodicity. While the pre-programming of infusion rates, times and amounts with infusion pumps enables a wide variety of treatment protocols that would be impractical, expensive or unreliable if performed manually, it also presents the challenge of safely controlling the introduction of fluids into a patient when medical personnel are not continuously present.
Medical infusion pumps can be classified as large volume or small volume. Large volume pumps are typically used for medications and fluids, such as nutrients, that need to be delivered to patients in relatively large volumes compared to other medications and fluids, while small volume pumps can be used to infuse insulin or other medicines such as opiates. While small volume pumps can take different forms, syringe pumps are one of several types of pumps that can provide precision infusion of small amounts of fluid.
A syringe pump typically employs a pre-filled medication syringe that is mechanically driven under microprocessor control to deliver a prescribed amount or dose of a fluid at a controlled rate to a patient through an infusion line fluidly connected to the syringe. Syringe pumps typically include a motor that rotates a leadscrew. The leadscrew in turn activates a plunger driver which forwardly pushes a plunger within a barrel of the syringe. Pushing the plunger forward thus forces the dose of medication outwardly from the syringe, into the infusion line, and to the patient—typically, intravenously. Examples of syringe pumps are disclosed in U.S. Pat. No. 4,978,335 titled “Infusion Pump with Bar Code Input to Computer”, U.S. Pat. No. 8,182,461 titled “Syringe Pump Rapid Occlusion Detection System”, and U.S. Pat. No. 8,209,060 titled “Updating Syringe Profiles for a Syringe Pump,” each of which is incorporated herein by reference in its entirety. As used throughout this disclosure, the term “syringe pump” is intended to generally pertain to any device which acts on a syringe to controllably force fluid outwardly therefrom.
Syringe pumps are used to control delivery to a patient of medications or fluids that include, but are not limited to: therapeutic agents; nutrients; drugs; medicaments such as antibiotics, blood clotting agents, and analgesics; and other fluids. The devices can be used to introduce the medications or fluids into the body of a patient utilizing any of several routes such as, for example, intravenously, subcutaneously, arterially, or epidurally.
To enhance patient safety during infusions, syringe pump manufacturers have developed so-called “smart” pumps that may provide functionality beyond just the delivery of fluids to a patient by the aforedescribed mechanical means. Smart pumps typically provide information concerning, or might even impose, safety limits on medication program parameters such as dose, concentration, and time, etc., for delivery of a particular medication from the pump to a particular patient. Consequently, more work may be required from practitioners to create and maintain so-called “drug libraries” associated with such safety limits. Provision of such functionality may be considered as being of higher importance in certain practices, protocols, and standardized procedures. There may be not as much emphasis or need for standardization, provision of pump safety limits, or restrictions on medication dosing rate ranges, however, with other practices and protocols. Thus, there is an unmet need for pumps that provide several levels of functionality.
In settings that typically do not require a high degree of functionality with safety limits and/or drug libraries for pumps, practitioners are usually accustomed to workflows that are much simpler than those of smart pumps. A simple workflow is usually defined as “Rate, Volume, Run” or a similar, basic controlled infusion protocol. Conversely, a more fully controlled infusion would typically employ applicable safety limits, which are commonly referred to as “hard” and “soft” limits, on delivery of a particular medication. A hard limit is often defined as a limit for which a selected infusion parameter that is outside of the limit results in generation of an alert and rendering of the pump inoperative or unable to accept selection or input of the parameter. Hard limits are typically set for high-risk drugs such as heparin. A soft limit, however, is often defined as a limit which may generate an alert but still may be overridden so that the infusion may proceed. When hard and/or soft limits are employed with a smart pump, information is usually input to the pump—or another system in communication with or controlling the pump—which includes data such as patient weight, the type of medication being infused, and the prescribed drug concentration. Typically a drug library contains a list of medications at predefined or standard concentrations, which in turn effectively determines safe dosing ranges. To program such a smart pump with a drug library, the practitioner would typically need to select the particular medication and concentration, enter the patient's weight, program the required infusion parameters such as dose and time, and then enter a command to start the infusion. These steps result in a more complicated workflow for practitioners.
Perhaps a larger challenge to smart pump workflows, however, is in preparing and setting running parameters, etc., before actual use of a pump with a patient. A clinical staff member such as a pharmacist would most likely need to develop a drug library with hard and soft limits for each medication and possibly for each drug concentration as well. In some cases these drug libraries or lists may exceed thousands of entries that need to be defined and entered prior to patient infusions. Developing and maintaining a drug library requires the management of a large number of drug lists, a large amount of hand-entered data, and therefore, involves a considerable amount of time. This problem is exacerbated in any transition to or from the traditional drug library storage component as part of a Hospital Information System (HIS).
It would therefore be useful and advantageous to provide medication safety devices and methods which would meet the needs of both a high and a lower functionality in setting limits and in drug libraries, and which could easily transition from a low functionality to create and maintain a more sophisticated drug library if desired.